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Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03863197
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : May 12, 2021
Sponsor:
Collaborators:
KU Leuven
University Ghent
Queen Fabiola Children's University Hospital
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE March 5, 2019
Last Update Posted Date May 12, 2021
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date June 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2020)
  • Change in muscle size parameter [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Estimation of muscle morphology parameters by 3D freehand ultrasonography.
  • Change in echogenicity intensity [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
  • Change in isometric muscle strength [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
  • Change in functional muscle strength [ Time Frame: baseline, mid- (6 weeks), post-intervention (12-weeks) ]
    Evaluation of functional muscle strength by the Adapted Functional Strength measure.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Change in muscle volume [ Time Frame: baseline, 6-weeks, post-intervention (12-weeks) ]
    Estimation of muscle volume by 3D freehand ultrasonography.
  • Change in echogenicity intensity [ Time Frame: baseline, 6-weeks, post-intervention (12-weeks) ]
    Estimation of echogenicity intensity by 3D freehand ultrasonography on an 8-bit greyscale (256 values).
  • Change in isometric muscle strength [ Time Frame: baseline, 6-weeks, post-intervention (12-weeks) ]
    Evaluation of isometric muscle strength by Instrumented Weakness Assessment.
  • Change in functional muscle strength [ Time Frame: baseline, 6-weeks, post-intervention (12-weeks) ]
    Evaluation of functional muscle strength by the Adapted Functional Strength measure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
Change in gross motor function [ Time Frame: baseline, post-intervention (12 weeks) ]
Evaluation of gross motor function by the Gross Motor Function Measure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 26, 2020)
  • Change in quality of life [ Time Frame: baseline, post-intervention (12 weeks) ]
    Evaluation of quality of life by the CP Quality of Life (CP QOL-Child) questionnaire for children. This questionnaire evaluates quality of life over various domains on a 1-9 scale. A higher score indicates more happiness.
  • Change in Functionality [ Time Frame: baseline, post-intervention (12 weeks) ]
    The level of functionality and activity is assessed by the Gillette Functional Assessment questionnaire. This parent-reported questionnaire consists of 22 items (0 low function - 10 high function).
  • Change in patient reported physical function [ Time Frame: Baseline, post-intervention (12 weeks) ]
    The perceived level of physical functioning is assessed by the Activities Scale for Kids
Original Other Pre-specified Outcome Measures
 (submitted: March 4, 2019)
  • Change in quality of life [ Time Frame: baseline, post-intervention (12 weeks) ]
    Evaluation of quality of life by the CP Quality of Life (CP QOL-Child) questionnaire for children. This questionnaire evaluates quality of life over various domains on a 1-9 scale. A higher score indicates more happiness.
  • Change in level of participation [ Time Frame: Baseline, post-intervention (12 weeks) ]
    Level of participation is assessed by the CAPE (Children's Assessment of Participation and Enjoyment) questionnaire. The self-reported level of enjoyment is rated on a five pint scale.
  • Change in Functionality [ Time Frame: baseline, post-intervention (12 weeks) ]
    The level of functionality and activity is assessed by the Gillette Functional Assessment questionnaire. This parent-reported questionnaire consists of 22 items (0 low function - 10 high function).
 
Descriptive Information
Brief Title  ICMJE Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Official Title  ICMJE Treatment Algorithms Based on Muscle and Tendon Morphology - Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Brief Summary A randomized controlled trail will be carried out to investigate the effect of a 12-week supervised home-based progressive strength intervention in children with spastic cerebral palsy aged 5-11 years. The results of this strength intervention aiming for increased strength and muscle hypertrophy will serve as input for a clinical decision making framework based on muscle and tendon architecture.
Detailed Description

Background: The alterations of morphological muscle and tendon properties are a primary determinant of the pathological muscle behaviour in spastic cerebral palsy (SCP). As treatments aim to reduce the progressive secondary problems, they are mainly directed at the muscle level. Muscle morphology features like volume, fascicle architecture and tendon properties are all responsive to treatment, but these treatment responses seem to be both patient and muscle-specific. Therefore, objective tools and protocols are needed for the evaluation of morphological muscle and tendon (MMT) properties in routine clinical practice. These are required to guide the patient-specific selection of appropriate, rationalized treatment choices and to determine the impact of these treatments on the MMT properties, the muscular impairment and function in children with SCP.

This intervention study is one out of three intervention studies focused on defining the effects of conservative treatments (strengthening, stretching and botulinum toxin injections) on muscle and tendon architecture. In this phase of the Treatment Algorithms based on Muscle and Tendon Morphology (TAMTA) project, we aim to develop specific guidelines for these treatment options linked to the MMT evaluation protocol. To achieve this goal, prediction models based on baseline MMT parameters for the prognosis of specific treatment outcomes will be developed from the data of the three intervention studies.

Aim: (1) determine whether the 12-week program of targeted progressive strengthening of the plantar flexors, the knee flexors and extensors leads to changes in the MMT properties of medial gastrocnemius, semitendinosus and rectus femoris, in the muscle strength and in gross motor function; and (2) determine the correlation between baseline MMT properties and the changes in the outcome parameters.

Methods/Design: A randomized controlled trial will be conducted in 40 ambulatory children with a confirmed diagnosis of SCP between 5 and 11 years of age. Participants will be randomized to the intervention group (who will additionally receive the strengthening program while continuing their usual care) or to the waitlist-control group (who will continue their usual care without additional treatment) using the randomization by minimization method (with influencing characteristics age and GMFCS level). Participants in the control group will be able to participate in the intervention after the control period. The MMT parameters of the medial gastrocnemius, tibialis anterior, semitendinosus and rectus femoris and the isometric and functional strength for the 4 related lower limb muscle groups (plantar flexors, dorsiflexors, knee flexors and knee extensors) as well as the gross motor function will be assessed before and after the 12-week program. After 6 weeks a short evaluation of the MMT parameters, isometric and functional strength will take place.

The change in primary outcome parameters before and after training of the intervention group will be compared to the data behaviour of the control group. Secondly, to explore the predictive value of specific baseline MMT parameters on treatment effect, both univariate and multivariate linear regression analyses will be conducted to identify significant predictive variables for the primary outcome parameters.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized controlled trial with waitlist control group
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy, Spastic
Intervention  ICMJE Behavioral: Progressive strength training
Progressive Supervised Home-based Strength Training
Study Arms  ICMJE
  • Experimental: Intervention group
    During a 12-week period children receive 3-4 sessions of progressive strength training per week on top of the usual care. All children will be provided with an individualized training program and supporting equipment. One or 2 session per week will be performed under supervision of the physical therapist, whilst the remaining sessions will be performed at home. Progression is closely monitored by the principal investigator and training programs are adjusted if necessary.
    Intervention: Behavioral: Progressive strength training
  • No Intervention: Waitlist-control group
    The waitlist-control group will continue their usual care without additional treatment for 12-weeks, followed by a 12-week period of progressive supervised home-based strength training.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2020)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
30
Estimated Study Completion Date  ICMJE June 10, 2021
Estimated Primary Completion Date June 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of SCP
  • Aged 5-12 years
  • GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
  • Sufficient cooperation to comprehend and complete the test procedure

Exclusion Criteria:

  • Non-ambulatory
  • Botulinum toxin A injections six months prior to enrollment
  • Lower limb surgery two years prior to enrollment
  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Britta Hanssen, MSc +3216341295 britta.hanssen@kuleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03863197
Other Study ID Numbers  ICMJE S59945
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE
  • KU Leuven
  • University Ghent
  • Queen Fabiola Children's University Hospital
Investigators  ICMJE
Study Director: Kaat Desloovere, Dr KU Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP